Recruiting multiethnic populations to preclinical Alzheimers disease trials

招募多种族人群参与临床前阿尔茨海默病试验

基本信息

批准号：
10677736
负责人：
Joshua Grill
金额：
$ 19.63万
依托单位：
UNIVERSITY OF CALIFORNIA-IRVINE
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-15 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10677736
关键词：
Acceleration Activities of Daily Living Address Affect African American Age Alzheimer disease prevention Alzheimer&apos s Disease Alzheimer&apos s disease related dementia Alzheimer’s disease biomarker Amyloid Asian Asian Americans Asian population Assessment tool Attitude Biological Markers Black Populations Black race Clinical Trials Clinical Trials Design Cognitive Communities Data Dementia Development Disclosure Disease Disparity Disparity in diagnosis Early Intervention Elderly Enrollment Ensure Ethics Ethics Committees Ethnic Population Face Failure Funding Future Goals Hispanic Hispanic Populations Human Impaired cognition Incentives Individual Intervention Intervention Studies Investigational Drugs Learning Literature Methods Not Hispanic or Latino Participant Pattern Persons Phase Placebos Population Heterogeneity Protocols documentation Public Health Published Comment Race Reporting Research Research Personnel Risk Role Safety Sampling Site Social Justice Spouses Testing Trust Visit asymptomatic Alzheimer&apos s disease clinical trial enrollment cognitive ability cognitive interview cohort design disorder risk ethnic difference experimental study health disparity improved informant multi-ethnic novel participant enrollment pre-clinical preclinical trial programs racial difference racial population recruit therapy development trial design willingness

项目摘要

PROJECT SUMMARY Preclinical Alzheimer’s disease clinical trials enroll cognitively normal participants who are willing to undergo disease biomarker testing, learn the results, and take an investigational drug (or placebo) if those results indicate that they are at increased risk for disease. Like traditional trials in Alzheimer’s disease dementia, these trials require participants to enroll with a study partner, a person who can attend visits with the participant and report about any changes in the participant’s cognitive or functional ability. These trials face difficult recruitment, especially in enrolling samples representative of the nation’s diverse population. Understanding potential differential attitudes toward the unique requirements in preclinical AD trials will be essential to instructing inclusive recruitment, enrollment, and conduct of preclinical AD trials. This project will examine potential differential attitudes toward preclinical AD trials among African American/Black, Asian American, Hispanic, and non-Hispanic White older cognitively unimpaired individuals. The project will focus on two key requirements in these trials: biomarker disclosure and the study partner requirement. There is strong rationale to hypothesize that these groups may differ in their attitudes toward these requirements. This includes our previous demonstration of differential attitudes toward the requirements based on whether an individual would enroll with a spouse as a study partner and the enrollment patterns of dyads in the first preclinical AD trial, the Anti-Amyloid treatment in Asymptomatic AD (A4) Study. In A4, 58% of non- Hispanic White participants enrolled with a spouse study partner, compared to 45% for Hispanic, 46% for Asian, and 27% for African American/Black participants. This project will provide critical data toward improving preclinical AD trial protocol designs and requirements, as well as practices in disclosure, to ensure diverse and inclusive recruitment that respects potential cultural differences in attitudes toward the requirements of these important studies.

项目概要临床前阿尔茨海默病临床试验招募愿意接受认知功能正常的参与者疾病生物标志物测试，了解结果，如果结果表明，则服用研究药物（或安慰剂）与阿尔茨海默病痴呆症的传统试验一样，这些试验也表明他们患疾病的风险增加。要求参与者与研究伙伴一起注册，研究伙伴可以与参与者一起进行访问并进行报告关于参与者认知或功能能力的任何变化这些试验面临招募困难，特别是在招募代表国家多元化人口的样本方面。对临床前 AD 试验的独特要求的不同态度对于指导至关重要包容性招募、入组和进行临床前 AD 试验。该项目将研究非洲人对临床前 AD 试验的潜在不同态度美国/黑人、亚裔美国人、西班牙裔和非西班牙裔白人认知未受损的老年人。该项目将重点关注这些试验中的两个关键要求：生物标志物披露和研究合作伙伴有充分的理由重新认识到这些群体对这些的态度可能不同。这包括我们之前对基于需求的不同态度的展示。关于个人是否会与配偶一起作为学习伙伴入学以及二人的入学模式第一个临床前 AD 试验，无症状 AD (A4) 研究中的抗淀粉样蛋白治疗，在 A4 中，58% 为非症状性 AD。西班牙裔白人参与者与配偶研究伙伴一起报名，相比之下，西班牙裔为 45%，亚裔为 46%，非裔美国人/黑人参与者为 27%。该项目将为改进临床前 AD 试验方案设计和要求提供关键数据，以及披露做法，以确保尊重潜在文化的多元化和包容性招聘对这些重要研究的要求的态度存在差异。